Multidimensional Biological Evaluation of Polydopamine-Modified SEBS Gels for Improved Safety

Area of Science:

• Biomaterials Science
• Materials Engineering
• Medical Device Development

Background:

• Styrene-ethylene-butylene-styrene (SEBS)-based elastomers are used in medical devices, but clinical translation is limited by safety concerns in physiological microenvironments.
• The hydrophobicity of SEBS and limitations of traditional testing models necessitate advanced evaluation frameworks for human tissue response.

Purpose of the Study:

• To synthesize a novel SEBS/paraffin oil gel functionalized with polydopamine (PDA) coatings.
• To establish a multiscale safety evaluation framework for assessing the biocompatibility of advanced medical elastomers.
• To enhance hydrophilicity and antimicrobial properties of SEBS elastomers for improved clinical applications.

Main Methods:

• One-pot synthesis of SEBS/paraffin oil gel followed by PDA functionalization.
• Mechanical characterization, including toughness and fatigue stability assessment.
• Multiscale safety evaluation using 3D human skin models, in vitro cytotoxicity assays, and in vivo animal studies.

Main Results:

• The synthesized SEBS gel demonstrated exceptional toughness and fatigue stability.
• PDA coating resulted in high cellular viability (>98%) and enhanced hydrophilicity.
• 3D organoid and animal studies confirmed negligible IL-6 upregulation and no skin irritancy, validating material safety.

Conclusions:

• The developed SEBS/PDA elastomer exhibits excellent mechanical properties and biocompatibility.
• The multiscale safety evaluation framework effectively predicts human tissue response, offering a standardized preclinical assessment.
• This work provides a translatable paradigm for the systematic evaluation of medical elastomers, facilitating clinical translation.